Business Wire

VALBIOTIS publishes its annual results for 2019

Share

Regulatory News:

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200420005808/en/

Valbiotis pipeline (Photo: Business Wire)

Valbiotis pipeline (Photo: Business Wire)

VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / eligible for the PEA/SME), a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces its results for the 2019 fiscal year and reviews its recent milestone achievements.

HIGHLIGHTS AND RESULTS 2019:

  • Priority given to the development of TOTUM-63, a plant-derived active substance with clinically demonstrated metabolic benefits in prediabetic patients.
  • €8M in cash flow as of 31 December 2019.

POST-CLOSING EVENTS AND OUTLOOK:

  • Signature of a global strategic partnership with Nestlé Health Science for the development and commercialization of TOTUM-63, including an upfront payment of CHF 5 million, milestone payments up to CHF 66 million, plus tiered royalties on net sales. The agreement also includes that VALBIOTIS will supply TOTUM-63 to Nestlé Health Science, which represents an additional source of revenue for the Company.
  • Launch of the last clinical development stage of TOTUM-63 by mid-2020 (Phase II/III study, REVERSE-IT).
  • Acceleration of the pipeline's clinical development through the launch of three Phase II studies in new indications: TOTUM-070 for lowering LDL-cholesterol, TOTUM-854 for lowering blood pressure and TOTUM-448 for decreasing hepatic steatosis.
  • Guaranteed collection of €6.3M in operating income over the coming weeks (including €4.7M in upfront payments from Nestlé Health Science in April; €1.2M from the 2019 Research Tax Credit; €0.4M in public funding).

Sébastien PELTIER, CEO and Chairman of the VALBIOTIS Board of Directors, says:

"In 2019, we focused all of our efforts on the development of TOTUM-63. Our aim was to form a partnership with a major healthcare player in order to finalize its clinical development and accelerate its commercialization. By signing a partnership agreement with Nestlé Health Science in early 2020, we have validated our business model as well as our R&D platform’s efficacy. With a strengthened cash position and newly established international recognition, we can speed up the development of all the products in our portfolio. Our ambition is clear: to provide effective products for all populations affected by metabolic diseases at early stages, to which solutions have yet to be found. We are convinced that our shareholders, who have placed their trust in us, will soon benefit from these steps forward, including the value of our agreement with Nestlé Health Science and our new R&D roadmap."

Highlights of 2019:

  • Priority given to the development of TOTUM-63

As mentioned above, VALBIOTIS' main focus in 2019 was the development of TOTUM-63, a patented innovative combination of five plant extracts designed to reduce the risk of Type 2 Diabetes in prediabetic patients. The company’s major milestone achievement was the announcement of positive results from the international Phase II clinical study (press releases from 3 July 2019 and 2 September 2019).

With regard to preparing market launch of TOTUM-63, the past year saw significant progress for VALBIOTIS with the acquisition of a European patent(press release from 11 February 2019), guaranteeing TOTUM-63’s exclusivityon the two main markets worldwide (Europe and the United States), as well as the validation of its industrial transposition(press release from 28 May 2019) to meet with European and North American regulations in partnership with the Pierre Fabre Group. These steps were instrumental in concluding the global strategic partnership agreement signed with Nestlé Health Science in February 2020.

  • A stronger management with complementary expertise

In addition to these major milestones in developing TOTUM-63, the management team was also strengthened over the course of the fiscal year. VALBIOTIS brought in Josep INFESTA, as Head of Global Business Development (as external consultant), and life science specialists, AEC Partners, to develop and negotiate the partnership to market TOTUM-63's (press release from 24 January 2019). VALBIOTIS also announced the appointment of Murielle CAZAUBIEL to the Board as Director of Development and Medical Affairs (press release from 4 February 2019) and Agnès TIXIER to the Supervisory Board (press release from 19 March 2019).

  • Boosted financial resources

To support this development, VALBIOTIS has obtained two grants from the Nouvelle-Aquitaine and Auvergne-Rhône-Alpes regions totaling €887K, of which €390K was paid in 2019 (press release from 2 April 2019), as well as the renewed support of Bpifrance for a total of €630K (reimbursable advance and innovation loan), €510K of which was paid in 2019. In addition to this public funding, the company successfully completed a capital increase with preferential subscription rights totaling €7.2M (press release from 31 October 2019) in order to secure its financing and conclude its strategic partnership with a major healthcare player under the best possible conditions.

Financial information 2019:financial resources mainly allocated to R&D

The company's IFRS-compliant 2019 financial statements were approved by the Board of Directors on 15 April 2020, following the business continuity principle. These were examined by auditors and are available on the VALBIOTIS website: valbiotis.com.

Income statement - IFRS in €K, as of 31 December

2019

2018

Operating income, including

1,913

1,509

Grants

602

46

Research Tax Credit

1,219

1,183

R&D expenses

(3,974)

(3,826)

Sales and marketing expenses

(1,473)

(1,059)

Overhead costs

(1,343)

(1,284)

Operating profit for the period

(5,157)

(4,876)

Operating profit

(5,157)

(4,876)

Earnings before tax

(5,504)

(4,967)

Net profit

(5,504)

(4,967)

IFRS in €K

2019

2018

Cash flow generated by activities

(4,946)

(4,546)

Cash flow from investment activities

(290)

(723)

Cash flow from financing activities

5,850

2,090

Variation in cash

614

(3,179)

Cash at end of period

8,033

7,419

During the 2019 fiscal year, operating income increased to €1,913K - a growth of 27% compared to 2018. This mainly consists of the Research Tax Credit acquired over the period (€1,219K) and grants (€602K booked for the 2019 fiscal year). VALBIOTIS' activity is currently focused on its products’ development, and therefore no significant turnover was achieved, as expected.

R&D expenditures were stable compared to the previous fiscal year at €3,974K, illustrating the continuation of preclinical research and clinical studies over the period. Sales-Marketing expenditures amounted to €1,473K (compared to €1,059K). This increase is due to the establishment of the partnership with AEC Partners and the support of Josep INFESTA to conclude the commercial partnership for TOTUM-63’s marketing. Finally, overhead costs totaled €1,343K in 2019 (compared to €1,284K). Net loss over the fiscal year reached a total of €5,504K.

Activity-generated Working Capital Requirements reached €4,946K over the fiscal year and investment-generated flows were negative at €290K. Flows from financing activities were positive at €5,850K, mainly due to the capital increase with preferential subscription rights carried out by the company in October 2019 for a net income of €6.2M.

As of 31 December 2019, VALBIOTIS had a cash position of €8,033K. This does not include receipt of the initial CHF 5 million paid by Nestlé Health Science at the end of April 2020, the €1.2M reimbursement of the 2019 Research Tax Credit payment and €0.4M in public grants receivable.

VALBIOTIS thus benefits from a solid financial situation enabling it to pursue its development plan.

Post-closing events and outlook:

  • Signature of a global strategic partnership with Nestlé Health Science for the development and commercialization of TOTUM-63

The start of the fiscal year was marked by the signature of a long-term strategic partnership agreement with Nestlé Health Science for the development and worldwide commercialization of TOTUM-63 (press release from 5 February 2020). According to the agreement, Nestlé Health Science will ensure the funding of TOTUM-63’s final development stages and its commercialization (which could take place before the health claim is obtained).

In exchange for the worldwide commercial rights, Nestlé Health Science has committed to an upfront payment of CHF 5 million, plus milestone payments totaling up to CHF 66 million and tiered royalties on net sales. The agreement also includes VALBIOTIS’ supply of TOTUM-63 to Nestlé Health Science, which represents an additional source of revenue. The terms of the agreement considerably strengthen VALBIOTIS' cash position.

  • Launch of the last clinical development stage of TOTUM-63

As part of the partnership with Nestlé Health Science, VALBIOTIS has announced the launch of the final Phase II/III clinical study by mid-2020 (press release from 2 April 2020). The study, named REVERSE-IT, will allow to confirm the positive results of the Phase II study on fasting glycemia. It will also extend TOTUM-63’s evaluation to untreated type 2 diabetic patients (early stage) in order to expand the final target population. REVERSE-IT was co-defined alongside Nestlé Health Science’s medical and regulatory teams, and will be conducted on 600 subjects across 30 clinical centers worldwide.

  • Accelerated clinical development of the pipeline in new indications

While developing TOTUM-63 through the partnership with Nestlé Health Science, VALBIOTIS also intends to pursue its pioneering strategy for preventing chronic metabolic diseases through accelerated clinical development of its pipeline of innovative active substances: TOTUM-070, TOTUM-854 and TOTUM-448. These substances, also resulting from the company's proprietary R&D platform, target early stages of chronic metabolic and cardiovascular diseases with unmet medical needs.

An advanced clinical development program has already been defined for each of these products (press release from 16 April 2020):

  • The first clinical study should be launched in the third quarter of 2020 with TOTUM-070, which is aimed at lowering blood LDL cholesterol (“bad cholesterol”), a risk factor for cardiovascular diseases. In particular, VALBIOTIS intends to obtain the first proprietary health claim in Europe and North America related to lowering LDL cholesterol for a product containing neither phytosterols nor red yeast rice.
  • In the fourth quarter of 2020, the Phase II clinical study for TOTUM-854, aimed at lowering blood pressure, should be launched. VALBIOTIS intends to obtain the first proprietary health claim, particularly in Europe and North America, related to lowering systolic blood pressure, another risk factor for cardiovascular diseases.
  • Finally, in the second half of 2021, VALBIOTIS is expected to launch a Phase II study on TOTUM-448, aimed at decreasing hepatic steatosis - a condition with a high risk of developing non-alcoholic steatohepatitis (NASH).

These clinical programs already benefit from non-dilutive public financing. VALBIOTIS has yet to receive more than €500K in grants for the TOTUM-070 program from the Nouvelle-Aquitaine region’s European Regional Development Fund (ERDF). As a reminder, the total amount of the grant was €890K, of which the company has so far received €364K. The TOTUM-854 and TOTUM-448 programs also benefit from a reimbursable advance and an innovation loan granted by Bpifrance up to an overall amount of €630K, €510K of which was paid in 2019.

VALBIOTIS' annual financial report from 31 December 2019 has been made available to the public and filed with the French Financial Markets Regulator (AMF). This document is available on our website: valbiotis.com (in the “Investors” section).

Furthermore, VALBIOTIS confirms that it complies with PEA/SME eligibility criteria, as specified in article D.221-113-5 of Enforcement Decree n°2014-283 of 4 March 2014, namely:

  • A total workforce of less than 5,000 employees;
  • A turnover of under €1.5 billion, or total assets of under €2 billion.

As such, VALBIOTIS shares are still included in PEA/SME accounts, which benefit from the same tax advantages as the traditional French shared savings plan (PEA).

ABOUT VALBIOTIS

VALBIOTIS is a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases in response to unmet medical needs.

VALBIOTIS has adopted an innovative approach, aiming to revolutionize healthcare by developing a new class of nutritional health solutions designed to reduce the risk of major metabolic diseases, based on a multi-target approach and made possible by the use of plant-based ingredients.

Its products are intended to be licensed to players in the health world.

VALBIOTIS was founded in La Rochelle in early 2014 and has formed numerous partnerships with top academic centers. The Company has established three sites in France – Périgny, La Rochelle (17) and Riom (63).

VALBIOTIS is a member of the "BPI Excellence" network and received the "Innovative Company" status accorded by BPI France. Valbiotis has also been awarded "Young Innovative Company" status and has received major financial support from the European Union for its research programs by obtaining support from the European Regional Development Fund (ERDF). VALBIOTIS is a PEA-SME eligible company.

Find out more about VALBIOTIS: www.valbiotis.com

Name: Valbiotis
ISIN code: FR0013254851
Mnemonic code: ALVAL

Disclaimer

This press release contains forward-looking statements about VALBIOTIS' objectives, based on rational hypotheses and the information available to the company at the present time. However, in no way does this constitute a guarantee of future performance, and these projections can be reconsidered based on changes in economic conditions and financial markets, as well as a certain number of risks and doubts, including those described in the VALBIOTIS core document, filed with the French Financial Markets Regulator (AMF) on 31 July 2019 (application number R19-030) as well in its supplement approved by the AMF on Octobre 9, 2019. These documents being available on the Company’s website (www.valbiotis.com). This press release, as well as the information contained herein, does not constitute an offer to sell or subscribe to, or a solicitation to purchase or subscribe to, VALBIOTIS' shares or securities in any country.

Contact information

CORPORATE COMMUNICATION / VALBIOTIS
Carole ROCHER / Marc DELAUNAY
+33 5 46 28 62 58
media@valbiotis.com

FINANCIAL COMMUNICATION / ACTIFIN
Stéphane RUIZ
+33 1 56 88 11 14
sruiz@actifin.fr

MEDIA RELATIONS / MADIS PHILEO
Guillaume DE CHAMISSO
+33 6 85 91 32 56
guillaume.dechamisso@madisphileo.com

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Idriverplus Joins the “Automate with Velodyne” Ecosystem29.5.2020 20:31:00 CESTPress release

Velodyne Lidar, Inc. and Idriverplus today announced an expanded partnership and Idriverplus inclusion into the Automated with Velodyne integrator ecosystem, which helps companies grow their businesses while using Velodyne lidar technology. Through the program, Velodyne will further collaborate with Idriverplus to support its continued innovation and promote Idriverplus autonomous vehicles, including street cleaners, passenger cars and logistics vehicles. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200529005589/en/ Velodyne Lidar, Inc. and Idriverplus announced an expanded partnership and Idriverplus inclusion into the Automated with Velodyne integrator ecosystem, which helps companies grow their businesses while using Velodyne lidar technology. (Photo: Velodyne Lidar) Recently, Velodyne signed a multi-year sales agreement with Idriverplus to provide Puck™ sensors for the mass production of autonomous vehicles. Idriverplu

Interim Data from the Open Label Phase 2 OPTIC Study of Iclusig ® (ponatinib) for Chronic Phase-CML Presented at the ASCO and EHA Virtual Meetings29.5.2020 14:00:00 CESTPress release

Incyte (Nasdaq:INCY) today announced that data from the interim analysis of the Phase 2 OPTIC (Optimizing Ponatinib Treatment In CML) trial, which was sponsored by Takeda and co-funded by Incyte, will be presented during an oral session at the upcoming 2020 American Society of Clinical Oncology Virtual Meeting (ASCO20; May 29 – May 31) (Abstract #7502)1; and at the virtual 25th Congress of the European Hematology Association (EHA25; June 11 – 14) (Abstract #S172)2. The OPTIC trial is an ongoing randomized, open-label study prospectively evaluating response-based dosing regimens of Iclusig® (ponatinib) over a range of three starting doses (45 mg, 30 mg, 15 mg) with the aim of optimizing its efficacy and safety in patients with chronic-phase chronic myeloid leukemia (CP-CML), who are resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy. With a median follow up of approximately 21 months, data from the interim analysis of the OPTIC trial show that the optimal benefit-r

Takeda Receives Positive CHMP Opinion for Pre-Filled Syringe Presentation of TAKHZYRO ® (lanadelumab) for Use as a Preventive Treatment for Hereditary Angioedema Attacks29.5.2020 14:00:00 CESTPress release

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on a Type II Variation regulatory application and recommended the approval of a pre-filled syringe presentation of TAKHZYRO® (lanadelumab). TAKHZYRO is a subcutaneous injectable prescription medication approved in Europe for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. HAE is a rare genetic disorder that results in recurrent attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat.1,2,3 “Our goal is to continuously innovate in all areas of HAE management,” said Isabel Kalofonos, Global Product Strategy Lead, HAE, Takeda. “This positive opinion marks another important step forward as we aim to enhance the experience of treatment administration for peo

Takeda to Present Data from the ICLUSIG ® (ponatinib) Clinical Trial Program that Could Prove Practice-Changing for the Treatment of Chronic-Phase CML29.5.2020 14:00:00 CESTPress release

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that interim analysis data from the Phase 2 OPTIC (Optimizing Ponatinib Treatment In CML) trial will be presented during an oral session at the virtual 56thAmerican Society of Clinical Oncology (ASCO) Annual Meeting and the 25thEuropean Hematology Association (EHA) Annual Meeting. The OPTIC trial is an ongoing, randomized, open-label study prospectively evaluating response-based dosing regimens of ICLUSIG® (ponatinib) over a range of three starting doses (45-, 30-, or 15-mg) with the aim of optimizing its efficacy and safety in patients with chronic-phase chronic myeloid leukemia (CP-CML) who are resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy. With a median follow-up of approximately 21 months, data from the interim analysis of OPTIC show that the optimal benefit-risk profile for ICLUSIG in patients with CP-CML is achieved with a daily starting dose of 45-mg and, upon achieving ≤1% BCR-A

Takeda Announces Compelling Data from the Phase 2 Trial of Pevonedistat Plus Azacitidine in Patients with Higher-Risk MDS29.5.2020 14:00:00 CESTPress release

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced the results of the Phase 2 Pevonedistat-2001 trial will be presented during oral sessions at the virtual 56thAmerican Society of Clinical Oncology (ASCO) Annual Meeting and the virtual 25thEuropean Hematology Association (EHA) Annual Meeting. The study evaluated pevonedistat plus azacitidine versus azacitidine alone in patients with rare leukemias, including higher-risk myelodysplastic syndromes (HR-MDS). These results show that the combination of pevonedistat and azacitidine is a highly active, promising therapeutic approach and suggest benefit in the HR-MDS subgroup across multiple clinically meaningful endpoints, including overall survival (OS), event-free survival (EFS), complete remission (CR) and transfusion independence, with a safety profile similar to azacitidine alone. The Pevonedistat-2001 trial was designed as a proof-of-concept study in patients with HR-MDS, higher-risk chronic myelomonocytic leukemi

LetsGetChecked Debuts FDA EUA-Authorized At-Home Coronavirus (COVID-19) Sure-track Test29.5.2020 13:57:00 CESTPress release

LetsGetChecked, the leading direct-to-consumer at-home health testing and insights company, announces today the authorization of the new Coronavirus (COVID-19) Sure-track Test for at-home consumer use by the U.S. Food and Drug Administration under an EUA. The new test is authorized to serve at-risk individuals with a proprietary at-home PCR nasal swab test that delivers accurate and definitive results within 24 hours. Offering an end-to-end model, LetsGetChecked’s new Sure-track Test introduces the most complete FDA EUA-authorized Coronavirus at-home testing solution. The at-home Coronavirus (COVID-19) test incorporates a nasal swab and PCR lab analysis, offering convenient and secure results in 24 hours. Unlike serology tests that detect the presence of antibodies, the at-home COVID-19 test determines the presence or absence of SARS-CoV-2 viral RNA. LetsGetChecked’s Sure-track Test is the only FDA EUA-authorized at-home Coronavirus (COVID-19) test that owns all aspects of the testing

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom